Prevacid OTC

Name: Prevacid OTC

How should I take Prevacid OTC (lansoprazole)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Lansoprazole is usually taken before eating. Prevacid OTC should be taken in the morning before you eat breakfast.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open a delayed-release capsule. Swallow it whole.

If you are unable to swallow a delayed-release capsule whole:

  • Open the capsule and sprinkle the medicine into a spoonful of pudding, applesauce, yogurt, cottage cheese, or strained pears. Swallow this mixture right away without chewing. Do not save the mixture for later use.

  • You may also dissolve the medicine in 2 ounces (1/4 cup) of apple juice, orange juice, or tomato juice. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more juice to the same glass, swirl gently and drink right away.

  • The delayed-release capsule contents may also be given through a nasogastric (NG) feeding tube. Open the capsule and sprinkle the medicine into 40 milliliters of apple juice (do not use any other liquid). Inject all of this mixture through the NG tube and into the stomach. Then flush the tube with more apple juice to wash the contents down.

Do not break, chew, or cut an orally disintegrating tablet, and do not swallow it whole. Allow the tablet to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

If you are unable to dissolve the orally disintegrating tablet in your mouth:

  • Place a 15-milligram tablet into an oral syringe and draw 4 milliliters of water into the syringe. If using a 30-milligram tablet, draw 10 milliliters of water into the syringe.

  • Shake the syringe gently until the tablet is dispersed. Then empty the syringe into your mouth within 15 minutes after mixing. Refill the syringe with water, shake gently, and empty into your mouth.

  • The lansoprazole disintegrating tablet may also be given through a nasogastric (NG) feeding tube as follows: Disperse the tablet in an oral syringe as directed above. Then inject the mixture through the NG tube into the stomach within 15 minutes. Flush the tube with 5 more milliliters of water to wash the contents down.

Take this medicine for the full prescribed length of time. Your symptoms may improve before your condition is completely treated.

Prevacid OTC should be taken only once daily for 14 days. Do not take more than one tablet every 24 hours. It may take up to 4 days for full effect. Allow at least 4 months to pass before you start another 14-day treatment with Prevacid OTC.

Call your doctor if your symptoms do not improve or if they get worse while you are taking lansoprazole. If you take Prevacid OTC, call your doctor if your heartburn gets worse over the 14-day treatment, or if you need treatment more than once every 4 months.

If you use lansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Store at room temperature away from moisture, heat, and light. Do not freeze the liquid medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Prevacid OTC (lansoprazole)?

If you also take sucralfate (Carafate), avoid taking it at the same time you take lansoprazole. Wait at least 30 minutes after taking lansoprazole before you take sucralfate.

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What other drugs will affect Prevacid OTC (lansoprazole)?

Ask a doctor or pharmacist if it is safe for you to use lansoprazole if you are also using any of the following drugs:

  • digoxin;

  • erlotinib;

  • ketoconazole;

  • methotrexate;

  • mycophenolate mofetil;

  • tacrolimus;

  • theophylline;

  • warfarin (Coumadin, Jantoven);

  • an antibiotic--ampicillin, clarithromycin;

  • HIV medicine--atazanavir, nelfinavir; or

  • iron-containing medicines--ferrous fumarate, ferrous gluconate, ferrous sulfate, and others.

This list is not complete. Other drugs may interact with lansoprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

For the Consumer

Applies to lansoprazole: oral capsule delayed release, oral packet, oral powder for suspension, oral tablet disintegrating delayed release

Along with its needed effects, lansoprazole (the active ingredient contained in Prevacid OTC) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lansoprazole:

More common
  • Diarrhea
  • skin rash or itching
Less common
  • Abdominal or stomach pain
  • increased or decreased appetite
  • joint pain
  • nausea
  • vomiting
Rare
  • Anxiety
  • cold or flu-like symptoms
  • constipation
  • increased cough
  • mental depression
  • muscle pain
  • rectal bleeding
  • unusual bleeding or bruising
Incidence not known
  • Abdominal or stomach tenderness
  • back or leg pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating
  • bloody, black, or tarry stools
  • change in mental status
  • chest pain
  • chills
  • clay colored stools
  • cough or hoarseness
  • dark or bloody urine
  • difficulty with swallowing
  • drowsiness
  • fast heartbeat
  • fever
  • general body swelling
  • high fever
  • hives
  • indigestion
  • loss of appetite
  • lower back or side pain
  • mood or mental changes
  • muscle spasms (tetany) or twitching seizures
  • nosebleeds
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the feet or lower legs
  • swollen or painful glands
  • tightness in the chest
  • trembling
  • unusual tiredness or weakness
  • yellow eyes or skin

Some side effects of lansoprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Dizziness
  • headache
Less common
  • Bleeding, blistering, burning, coldness, or discoloration of the skin
  • mild nausea
Rare
  • Acid or sour stomach
  • bad, unusual or unpleasant (after) taste
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • feeling faint, dizzy, or lightheaded
  • feeling of heat or warmth
  • flushing or redness of the skin, especially on the face and neck
  • mild diarrhea
  • mild headache
  • mild vomiting
  • stomach discomfort or upset
  • sweating
Incidence not known
  • Decrease in passing urine (dribbling)
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficulty with speaking

For Healthcare Professionals

Applies to lansoprazole: compounding powder, intravenous powder for injection, oral delayed release capsule, oral granule for reconstitution, oral suspension, oral tablet disintegrating

General

The most commonly reported side effects include headache, dizziness, fatigue, and malaise.[Ref]

Gastrointestinal

Pseudomembranous colitis may occur with triple therapy for the eradication of H. pylori.

The majority of patients with severe/protracted cases of diarrhea who discontinued treatment had symptom resolution.[Ref]

Common (1% to 10%): Nausea, diarrhea, stomachache/abdominal pain/epigastric discomfort, constipation, vomiting, dry/sore mouth/throat, flatulence, benign fundic gland polyps
Rare (0.01% to 0.1%): Glossitis, candidiasis of the esophagus, taste disturbances, pancreatitis
Very rare (less than 0.01%): Macroscopic/microscopic colitis, stomatitis
Frequency not reported: Dyspepsia, pseudomembranous colitis, abdomen enlarged, halitosis, abnormal stools, bezoar, cardiospasm, dysphagia, enteritis, eructation, esophageal stenosis/ulcers/disorder, esophagitis, fecal discoloration, gastric nodules, gastritis, gastroenteritis, gastrointestinal anomaly/disorder/hemorrhage, gum hemorrhage, hematemesis, hiatal hernia, impaired gastric emptying, increased salivation, melena, mouth ulceration, gastrointestinal moniliasis, rectal disorder/hemorrhage, tongue disorder, ulcerative colitis/stomatitis, tenesmus, duodenitis, positive fecal occult blood
Postmarketing reports: Clostridium difficile associated diarrhea[Ref]

Dermatologic

Common (1% to 10%): Urticaria, pruritus/itching, rash
Rare (0.01% to 0.1%): Petechia, hair loss/thinning/alopecia, erythema multiforme, photosensitivity, hyperhidrosis/sweating
Very rare (less than 0.01%): Steven-Johnson syndrome, toxic epidermal necrolysis/fatal toxic epidermal necrolysis
Frequency not reported: Subacute cutaneous lupus erythematosus (erythematous/bullous rashes), acne, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, skin disorder[Ref]

Skin rashes, urticaria, and pruritus generally resolved upon discontinuation of therapy.[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Rare (0.01% to 0.1%): Vertigo, paresthesia, taste disturbance/loss/perversion, somnolence, tremor
Frequency not reported: Cerebrovascular accident/cerebral infarction, migraine, amnesia, convulsion, dementia, hemiplegia, hyperkinesia, hypertonia, hypesthesia, parosmia
Postmarketing reports: Speech disorder[Ref]

Hepatic

Common (1% to 10%): Increased liver enzyme levels (ALT, AST, GGTP, alkaline phosphatase)
Rare (0.01% to 0.1%): Hepatitis, jaundice
Frequency not reported: Cholelithiasis, bilirubinemia
Postmarketing reports: Hepatotoxicity[Ref]

Other

Common (1% to 10%): Fatigue
Rare (0.01% to 0.1%): Fever
Frequency not reported: Asthenia, candidiasis, flu syndrome, infection (not otherwise specified), chills, malaise, pain, thirst, deafness, ear disorder, otitis media, tinnitus, metaplasia, increased globulins, additional isolated laboratory abnormalities[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Fracture of the hip/wrist/spine, arthralgia, myalgia
Frequency not reported: Back pain, neck pain, neck rigidity, arthritis, bone/joint disorder, leg cramps, musculoskeletal pain, myasthenia, synovitis
Postmarketing reports: Myositis, systemic lupus erythematosus[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia, eosinophilia, leukopenia
Rare (0.01% to 0.1%): Anemia, purpura
Very rare (less than 0.01%): Agranulocytosis, pancytopenia
Frequency not reported: Neutropenia, bruising, hemolysis, lymphadenopathy, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, hemoglobin decreased, increased/decreased/abnormal platelets
Postmarketing reports: Aplastic anemia, hemolytic anemia, thrombotic thrombocytopenic purpura[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression
Rare (0.01% to 0.1%): Insomnia, hallucination, confusion, restlessness
Frequency not reported: Abnormal dreams, agitation, anxiety, apathy, depersonalization, emotional lability, hostility aggravated, libido increased/decreased, nervousness, neurosis, sleep disorder, abnormal thinking[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Edema
Frequency not reported: Peripheral edema, chest pain (not otherwise specified), contusion, angina, arrhythmia, bradycardia, hypotension, hypertension, myocardial infarction, palpitations, shock/circulatory failure, syncope, tachycardia, vasodilation[Ref]

Genitourinary

Rare (0.01% to 0.1%): Impotence
Frequency not reported: Urinary tract infection, pelvic pain, abnormal menses, breast enlargement/pain/tenderness, dysmenorrhea, dysuria, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency/retention/urgency, urination impaired, vaginitis, crystal urine present, albuminuria, hematuria[Ref]

Metabolic

A definitive relationship between use of this drug and hyponatremia has not been established.[Ref]

Rare (0.01% to 0.1%): Anorexia
Very rare (less than 0.01%): Increased cholesterol/triglyceride levels, hyponatremia
Frequency not reported: Hypomagnesemia, increased appetite, diabetes mellitus, avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, weight gain/loss, blood potassium increased, decreased cholesterol, increased LDH, hyperlipemia, hunger, increased/decreased electrolytes[Ref]

Ocular

Rare (0.01% to 0.1%): Visual disturbances
Frequency not reported: Ptosis, diplopia, abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, dry eyes, eye disorder/pain, glaucoma, photophobia, retinal degeneration/disorder, visual field defect[Ref]

Renal

Rare (0.01% to 0.1%): Interstitial nephritis
Frequency not reported: Renal failure/impairment, kidney calculus, kidney pain, increased creatinine, blood urea increased, glycosuria[Ref]

Some cases of interstitial nephritis resulted in renal failure.[Ref]

Endocrine

Rare (0.01% to 0.1%): Gynecomastia
Frequency not reported: Goiter, hypothyroidism, increased glucocorticoids, increased gastrin levels[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Angioedema
Very rare (less than 0.01%): Anaphylaxis/anaphylactic shock
Frequency not reported: Allergic reaction
Postmarketing reports: Anaphylactoid reactions[Ref]

Respiratory

A definitive relationship between use of this drug and interstitial pneumonia has not been established.[Ref]

Frequency not reported: Wheezing, upper respiratory tract inflammation/infection, interstitial pneumonia, asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, hoarseness, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, rhinitis, sinusitis, stridor[Ref]

Oncologic

Frequency not reported: Carcinoma/skin carcinoma, laryngeal neoplasia[Ref]

Some side effects of Prevacid OTC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

(web3)